| CTRI Number |
CTRI/2018/03/012287 [Registered on: 01/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study two devices, Proseal LMA and I-gel when used during surgery in children under anaesthesia |
|
Scientific Title of Study
|
Comparison of Proseal LMA with I-gel in children under controlled Ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen S |
| Designation |
Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
praveen4267@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tejesh C A |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejesh C A |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College,
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr.Praveen S, Resident in anaesthesiology, MS Ramaiah Medical College, Bangalore |
|
|
Primary Sponsor
|
| Name |
Tejesh C A |
| Address |
Department of Anaesthesiology,
MS Ramaiah Medical College & Hospitals, Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Praveen S |
MS Ramaiah Hospital |
Department of Anaesthesiology,
MS Ramaiah Medical College Hospitals,
New BEL Road,
Gokula,
Bangalore
Bangalore
KARNATAKA |
9901028977
praveen4267@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MS Ramaiah College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy children without any comorbidities undergoing surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-gel |
I-gel sizes 2 & 2.5 will be inserted by a standard technique as prescribed by the manufacturer of the device |
| Intervention |
Proseal LMA |
Proseal LMA sizes 2 & 2.5 will be inserted by a standard technique as prescribed by the manufacturer of the device |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Children weighing between 10-30kgs
2)American Society of Anaesthesiologists (ASA) Grade I and II
3)Duration of surgery <2hrs |
|
| ExclusionCriteria |
| Details |
1)Anticipated difficult airway.
2)History of obstructive sleep apnoea.
3)Risk of aspiration of gastric contents.
4)Laproscopic surgeries.
5)Prone position.
6)Intraoral surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the two devices in terms of oropharyngeal sealing pressure under controlled ventilation in children |
Oropharyngeal sealing pressure will be assessed immediately after insertion of the device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Success rate, insertion time, ease of insertion, fibreoptic-laryngeal view and ability to pass gastric tube of Proseal LMA and i-gel |
Immediately after insertion of the device |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2015 |
| Date of Study Completion (India) |
01/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This was a randomised study comparing the two supraglottic airway devices Proseal LMA and I-gel in 70 ASA 1 & 2 children aged 1-10years, weighing 10-30kg who are scheduled to undergo elective surgery under general anaesthesia. The primary outcome was to compare the oropharayngeal sealing pressure among the two devices.The oropharyngeal sealing pressure with the two devices was similar between the two devices. |